Events

CLAY ADAMS Dynac III Centrifuge 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & Co. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    54076
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1069-2010
  • 사례 시작날짜
    2009-08-17
  • 사례 출판 날짜
    2010-03-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-04-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87369
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Cenrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
  • 원인
    Medical laboratory centrifuge component may have been assembled incorrectly and cause disabling of the safety feature which prevents customers from opening the centrifuge while it is spinning.
  • 조치
    An "Urgent Product Recall" letter dated August 2009 was sent to the customers. The letter described the affected product, problem and the action to be taken by customers. The customers were advised to discontinue use of the centrifuge for repair or replacement with refurbished unit , provide an Excel file or a list with name, address and telephone number of end-users who were shipped this product from their distribution branches so that BD may inform them of the issue,and return the enclosed response form. For further assistance regarding product replacement and returns contact our Technical Services Department at 1-800-638-8663.

Device

CLAY ADAMS Dynac III Centrifuge
  • 모델명 / 제조번호(시리얼번호)
    Serial Number: 4510001, 4510002, 4510003, 4510004, 4510005, 4510006, 4510007, 4510008, 4510009, 4510010, 4510011, 4510012, 4510013, 4510014, 4510015, 4510016, 4510017, 4510018, 4510019, 4510020, 4510021, 4510022, 4510023, 4510024, 4510025, 4510026, 4510027, 4510028, 4510029, 4510030, 4510031, 4510032, 4510033, 4510034, 4510035, 4510036, 4510037, 4510038, 4510039, 4510040, 4510041, 4510042, 4510043, 4510044, 4510045, 4510046, 4510047, 4510048, 4510049, 4510050, 4510051, 4510052, 4510053, 4510054, 4510055, 4510056, 4510057, 4510058, 4510059, 4510060, 4510061, 4510062, 4510063, 4510064, 4510065, 4510066, 4510067, 4510068, 4510069, 4510070, 4510071, 4510072, 4510073, 4510074, 4510075, 4510076, 4510077, 4510078, 4510079, 4510080, 4510081, 4510082, 4510083, 4510084, 4510085, 4510086, 4510087, 4510088, 4510089, 4510090, 4510091, 4510092, 4510093, 4510094, 4510095, 4510096, 4510097, 4510098, 4510099, 4510100, 4510101, 4510102, 4510103, 4510104, 4510105, 4510106, 4510107, 4510108, 4510109, 4510110, 4510111, 4510112, 4510113, 4510114, 4510115, 4510116, 4510117, 4510118, 4510119, 4510120, 4520001, 4520002, 4520003, 4520004, 4520005, 4520006, 4520007, 4520008, 4520009, 4520010, 4520011, 4520012, 4520013, 4520014, 4520015, 4520016, 4530001, 4530002, 4530003, 4530004, 4530005, 4530006, 4530007, 4530008, 4530009, 4530010, 4530011, 4530012, 4530013, 4530014, 4530015, 4530016, 4530017, 4530018, 4530019, 4530020, 4540001, 4540002, 4540003, 4540004, 4540005, 4540006, 4540007, 4540008, 4540009, 4540010, 4540011, 4540012, 4540013, 4540014, 4540015, 4540016, 4540017, 4540018, 4540019, 4540020, 4540021, 4540022, 4540023, 4540024, 4540025, 4540026, 4540027, 4540028, 4540029, 4540030, 4540031, 4540032, 4540033, 4540034, 4540035, 4540036, 4540037, 4540038, 4540039, 4540040, 4540041, 4540042, 4540043, 4540044, 4540045, 4540046, 4540047, 4540048, 4540049, 4540050, 4540051, 4540052, 4540053, 4540054, 4540055, 4540056, 4540057, 4540058, 4540059, 4540060, 4540061, 4540062, 4540063, 4540064, 4540065, 4540066, 4540067, 4540068, 4540069, 4540070, 4540071, 4540072, 4540073, 4540074, 4550001, 4550002, 4550003, 4550004, 4550005, 4550006, 4550007, 4550008, 4550009, 4550010, 4550011, 4550012, 4550013, 4550014, 4550015, 4550016, 4560001, 4560002, 4560003, 4560004, 4560005, 4560006, 4560007, 4560008, 4560009, 4560010, 4560011, 4560012, 4560013, 4560014, 4560015, 4560016, 4570001, 4570002, 4570003, 4570004, 4570005, 4570006, 4570007, 4570008, 4570009, 4570010, 4570011, 4570012, 4570013, 4570014, 4570015, 4570016, 4570017, 4570018, 4570019, 4570020, 4570021, 4570022, 4570023, 4570024, 4570025, 4570026, 4570027, 4570028, 4570029, 4570030, 4570031, 4570032, 4570033, 4570034, 4570035, 4570036, 4570037, 4570038, 4570039, 4570040, 4570041, 4570042, 4570043, 4570044, 4570045, 4570046, 4570047, 4570048, 4580001, 4580002, 4580003, 4580004, 4580005, 4580006, 4580007, 4580008, 4580009, 4580010, 4580011, 4580012, 4580013, 4580014, 4580015, 4580016, 4580017, 4580018, 4580019, 4580020, 4580021, 4580022, 4580023, 4580024, 4580025, 4580026, 4580027, 4580028, 4580029, 4580030, 4580031, 4580032, 4590001, 4590002, 4590003, 4590004, 4590005, 4590006, 4590007, 4590008, 4590009, 4590010, 4590011, 4590012, 4590013, 4590014, 4590015, 4590016, 4590017, 4590018, 4590019, 4590020, 4590021, 4590022, 4590023, 4590024, 4590025, 4590026, 4590027, 4590028, 4590029, 4590030, 4590031, 4590032, 4590033, 4590034, 4590035, 4590036, 4590037, 4590038, 4590039, 4590040, 4600001, 4600002, 4600003, 4600004, 4600005, 4600006, 4600007, 4600008, 4600009, 4600010, 4600011, 4600012, 4600013, 4600014, 4600015, 4600016, 4600017, 4600018, 4600019, 4600020, 4600021, 4600022, 4600023, 4600024, 4610001, 4610002, 4610005, 4610006, 4610008
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and Mexico, Phillipines, Columbia, Chile, Ecuador, Venezuela, Puerto Rico, Canada and Singapore.
  • 제품 설명
    CLAY ADAMS¿ Dynac¿ III Centrifuge, 120V, Model Number 420104 || DYNAC III is a multi-purpose centrifuge, designed for clinical laboratories performing separations in hematology, chemistry, urinalysis, blood banking, microbiology and cytology.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.